Objective To establish the standard operating procedures (SOPs) and quality control standards for the scientific management of centrally procured drugs in medical institutions of Sichuan Province, thereby facilitating the effective implementation of national centralized drug procurement policies and ensuring standardized, routine, and systematic management across all levels of medical institutions. Methods Based on national centralized procurement policy requirements and the practical management needs of medical institutions, this study adopted a multi-method approach, including iterative questionnaire surveys, Delphi expert consultation, and consensus meetings, to systematically identify and evaluate key processes and control elements in the end-to-end management of centrally procured drugs. Results A comprehensive management framework encompassing 14 critical components was successfully developed, including organizational structure, procurement volume estimation, contract allocation, shortage response, usage monitoring, quality supervision, and clinical evaluation incentives.Standardized opera-ting procedures and quality control criteria support this framework.This framework is supported by standardized operating procedures and quality control criteria. Conclusions The formulated standards provide medical institutions with replicable and actionable management tools, contributing to the enhancement of scientific and refined management of centrally procured drugs.These measures help ensure the safety, efficacy, and cost-effectiveness of clinical drug use, providing robust, practical support for deepening the reform of the pharmaceutical and healthcare systems.
To introduce the revision of the second method,the sieving method,in General Chapter 0982 "Determination of Particle Size and Particle Size Distribution" of the Pharmacopoeia of the People's Republic of China (Chinese Pharmacopoeia) 2025 Edition.By comparing the differences between the sieving methods in the 2025 edition and the 2020 edition of the Chinese Pharmacopoeia,this summary highlights improvements to the sieving method,providing references for implementing the standard.The revision of the sieving method in the 2025 Edition of the Chinese Pharmacopoeia is proposed based on the application characteristics of the sieving method in China's pharmaceutical industry and the international coordination requirements of ICH Q4B Annex 12.It transforms the relevant control requirements of the ICH Q4B sieving method into the general chapters of the Chinese Pharmacopoeia,achieving international coordination of the Chinese Pharmacopoeia.The revised determination method not only takes into account the actual needs of China's pharmaceutical industry but also supports international coordination,thereby improving the quality and efficacy of Chinese medicines.
Objective To optimize the extraction process of the compound preparation Wenyang Antai ointment (WYAT) and investigate its potential immunomodulatory active substance basis and underlying mechanism of action. Methods The extraction process of WYAT was optimized through multiple water absorption tests and an orthogonal design (investigated factors:water addition amount,number of extractions,and extraction duration),and the process stability was verified.An UPLC-ESI-QTRAP-MS/MS was employed for the widely targeted metabolomics analysis of WYAT.Network pharmacology (Swiss ADME,Swiss Target Prediction,STRING database,GO/KEGG enrichment analysis,and PPI network construction) was comprehensively applied to screen the immunomodulatory active components and potential targets of WYAT,which were further validated by molecular docking.Using mouse macrophage RAW264.7 cells as a model,the effects of WYAT on cell proliferation,cytokine secretion (TNF-α,IL-6),cell surface molecule expression (CD80,CD86,MHCⅡ),and related gene expression (TNF-α,IL-6,IL-1β,iNOS,IL-10) were evaluated through CCK-8 assay,ELISA,flow cytometry,and qRT-PCR. Results The optimized extraction process was as follows: adding 8-fold the water volume,decocting for three times,each for 2.5 hours;the verification experiments indicated that the process was stable.Metabolomics identified 923 components in WYAT,among which alkaloids and flavonoids accounted for a relatively high proportion (42.91%).Network pharmacology screened out 205 potential active components and 396 key immunomodulatory targets,and GO/KEGG analysis showed that their functions were mainly involved in signal transduction,inflammatory response,and signaling pathways such as PI3K-Akt and MAPK;molecular docking confirmed that core targets (IL-6,STAT3,etc.) bound stably to active components (all binding energies were <-22.2 kJ·mol-1).Cellular experiments demonstrated that WYAT (1.00-5.00 mg·mL-1) was non-cytotoxic and dose-dependently promoted the proliferation of RAW264.7 cells,significantly increased the secretion of TNF-α and IL-6 (up to 23.07-fold and 126.45-fold increases,respectively,P<0.05),significantly upregulated the expression of cell surface molecules CD80,CD86,and MHCⅡ (P<0.05),and significantly elevated the IL-1β mRNA level (P<0.05). Conclusions The stable extraction process of WYAT was successfully optimized.WYAT is rich in alkaloids and flavonoids,which can significantly activate macrophages through multiple components,targets,and pathways (especially the PI3K-Akt and MAPK pathways,as well as targets such as IL-6 and STAT3),thereby promoting macrophage proliferation and activation,cytokine secretion,and immunomodulatory effects.
Objective To systematically evaluate the quality status of fusidic acid cream and investigate the main factors affecting its quality. Methods Combined with legal standard testing and exploratory research based on national drug sampling and testing,comparative quality analysis was conducted on 122 batches of fusidic acid cream. Key quality attributes including microstructure,crystal form,viscosity,rheology,in vitro release and transdermal penetration,antioxidant,assay,content uniformity,related substances,and packaging material compatibility were emphatically investigated. Results Quality differences were observed among products from different manufacturers.Individual batches failed the particle size specification,and crystal transformation was detected in samples from several manufacturers.The particle size and crystal form of the active pharmaceutical ingredient (API) exerted certain effects on the in vitro release and penetration behavior of the drug.Distinct differences in microscopic morphology were found between generic products and the reference listed drug,reflecting gaps in critical process controls such as homogenization and API dispersion.The impurity profiles of products from domestic consistency-evaluated manufacturers were that of the reference drug.Prescription formulation,storage temperature and raw material quality were identified as the major factors influencing product quality. Conclusions Pharmaceutical manufacturers should optimize their formulations and critical manufacturing processes,strengthen raw material control and storage temperature management.Furthermore,the quality standards should be improved and whole-process supervision enhanced to the controllability and stability of fusidic acid cream.
Objective To systematically evaluate the quality profile of esmolol hydrochloride injections based on national drug sampling and testing,to assess their safety,efficacy,and potential quality risks,and provide references and suggestions for control in order to improve quality standards. Method A comprehensive evaluation was conducted on 77 sampled batches using statutory standards combined with exploratory studies,including related substances,hemolysis testgenotoxic impurities and other quality indicators. Results The compliance rate under statutory standards was 100.0%.Exploratory analyses revealed variations in related substance profiles between the 10 mL:0.1 g and the 2 mL:0.2 g specifications,as well as differences in hemolysis rate among products from certain manufacturers. Conclusions Esmolol hydrochloride injections demonstrate satisfactory quality,though existing standards require further refinement related substances for the 2 mL:0.2 g specification.Manufacturers are advised to optimize their formulations and manufacturing processes.
Objective To evaluate the quality of laminated/coated elastomeric closures for injections based on national drug sampling and testing,the existing problems were analyzed to provide suggestions for the production,quality control and regulatory. Methods A comprehensive evaluation of 36 batches of samples for national drug sampling and testing in 2025 was conducted by enterprise standard inspection and exploratory research,including safety,compatibility,performance,protection,self-stability and standard suitability. Results The enterprise standard inspection compliance rate was 91.7%.Exploratory research confirmed laminated/coated elastomeric closures possessed excellent chemical stability and compatibility, however,some samples were found to have problems in self-stability,component fitness and standard clause setting. Conclusion It is recommended that pharmaceutical packaging manufacturers enhance monitoring of production process and quality control,drug manufacturers improve the understanding of the packaging system as a whole, and the enterprise standard be further refined.
Objective To evaluate the quality of paracetamol tablets based on national drug sampling tests,to analyze existing quality problems,and to provide references and suggestions for the production,quality control,and supervision of this production. Methods Two hundred and eighty-nine batches of paracetamol tablet samples were spot checked.Through statutory specifications and exploratory research,the causes of unqualified samples, in vitro dissolution profiles,antioxygen thiourea,scored-tablets,and related substances were studied and evaluated. Results The qualification rate of samples according to the statutory specification was 99.7%,which was higher than that in previous national drug sampling tests.One batch product that passed the consistency evaluation was found to be abnormal in dissolution.The exploratory study results indicated that 5 manufacturers pro-ducts suspected of failing the consistency evaluation.of unauthorized thiourea addition and not producing according to the approved prescription process.The results of the in vitro dissolution profiles indicated that the quality of the products have passed the consistency evaluation is superior to that of the products have not passed the consistency evaluation. Conclusions The overall quality status of the products have passed the consistency evaluation is superior to that of the products have not passed the consistency evaluation,the consistency evaluation of generic drugs could promote the quality improvement of paracetamol tablets.The manufacturers should strictly adhere to the approved prescription and production processes,strengthen precisely control over key manufacturing parameters,and enhance their emphasis on the consistency evaluation of generic drugs.
Objective Based on the national drug sampling and testing, this study conducted a safety and quality evaluation of Shenmei Yangwei granules in accordance with the variety characteristics of the preparation, sorted out the key points of safety research in sampling inspection, and put forward regulatory and enterprise quality control suggestions combined with the evaluation results, to provide support for ensuring the safety of public medication. Methods Ultra-performance liquid chromatography (UPLC) was adopted to determine the paeoniflorin sulfite as the indicator for the sulfur-fumigation inspection of Radix Paeoniae Alba in Shenmei Yangwei granules, and a reasonable limit was formulated.High-performance liquid chromatography-mass spectrometry (HPLC-MS) was used to inspect 36 prohibited colorants, screen other exogenous harmful substances, heavy metal and harmful element residues, 47 prohibited pesticide residues, 10 mycotoxins, and plant growth regulator residues.Thus, the quality and safety of 148 batches of Shenmei Yangwei granules. Results Exploratory studies showed that: the paeoniflorin sulfite content in samples from some enterprises exceeded the proposed limit, indicating that the sulfur dioxide residue in the input Radix Paeoniae Alba exceeded the standard;prohibited colorants were detected in samples from some enterprises, suggesting that the input Flos Carthami had been illegally dyed, which posed potential safety risks to medication. Conclusions The safety-related issues found in this random inspection should be taken seriously and rectified.It is suggested that enterprises should pay attention to supplementary testing methods raw and auxiliary materials, establish reasonable internal quality control standards, and strictly control the quality of incoming raw materials during acceptance to ensure the quality of the input medicinal materials.
Objective To evaluate the quality status of commercially available fibrinogen and compare the inherent differences in products from different enterprises. Methods A total of 21 batches of samples from 7 companies were inspected accord legal quality standards,and research was conducted on four aspects: residual investigation of borne viruses (human parvovirus B19 and cytomegalovirus),stability,protein composition,and aluminum ion residue.Conduct statistical analysis on the results of testing according to legal standards and exploratory comprehensively evaluate the quality status of human fibrinogen. Results The legal standard inspection pass rate of 21 batches of samples was 100%.The exploratory research results showed that the residual DNA of human cytomegalovirus was negative,and 38% of the samples were detected to have residual DNA of human parvovirus B19. The thermal stability of products from different enterprises varies greatly,which may be related to protective agents,with higher purity observed in products exhibiting better thermal stability. A total of 3 to 10 heteroproteins were identified across the 7 manufacturers,with low levels of fibronectin and plasminogen in all products.One enterprise used aluminum hydroxide gel for adsorption,and the residual aluminum ion was significantly higher of other enterprises. Conclusions The overall quality of this product is good,but there is still a need to strengthen control of human parvovirus B19 load and gradually improve and process to enhance product stabilityrisks of impurities and aluminum ion residues.The research can provid technical support for enhancing the quality of commercially available human fibrinogen.
Investigator-initiated trials (IIT) conducted by healthcare institutions exhibit diverse funding sources and rapid quantitative growth.IIT contracts are legally binding agreements that define rights and obligations in clinical research colla-borations between hospitals and external parties;their risk management has become a critical component of hospital clinical research administration.However,fragmented management,insufficient standardization,and a lack of standardization processes in IIT contracts have elevated contract risk prevention as a significant challenge in hospital governance.From the perspective of risk ma-nagement and the internal control requirements of hospital functional departments,this study analyzes the current state of funded IIT contract management.It reconstructs an analytical framework based on contract life-cycle phases,identifies and mitigates risks across the entire contract life cycle,and proposes a comprehensive risk control system encompassing "preventive measures,real-time monitoring,and post-event feedback" to promote the refinement and intelligence transformation of clinical research in healthcare institutions.
Objective To construct a scientific and feasible quality control index system for investigator-initiated clinical research on cell therapy. Methods The literature analysis method was used to initially formulate quality control indicators.After discussions by the research team,a pool of quality control indicator items was formed.Two rounds of expert consultation were conducted among 20 experts using the expert consultation method to determine the indicators and construct the quality control index system. Results The effective recovery rates of the two rounds of questionnaires were 100% and 95%,respectively,and the expert authority coefficient was 0.90.The final quality control index system was established,which included 14 first-level indicators and 52 second-level indicators across 3 phases. Conclusion The quality control index system constructed in this study has high recognition and can provide reference for researchers and management departments to carry out quality management.
Objective To explore the research status and future trend of mesenchymal stem cells (MSCs) related clinical trials in China,and to provide a reference for MSCs drug research and development. Methods To retrieve the clinical trials related to MSCs in China from the establishment of the registration and information publicity platform of drug clinical trials of the national medical products administration to September 25,2025,and to extract relevant data and information for inductive analysis. Results A total of 65 MSCS-related clinical trials were retrieved,of which 43 items (66.15%) were multi-center studies,recruiting a total of 3 112 participants.The sponsoring institutions and implementation team leaders were concentrated in Shanghai,Beijing,Guangdong,Zhejiang,and other provinces and cities with developed economic and abundant medical resources.There were 34 (52.31%) parallel-group designs and 31 (47.69%) single-arm trials.One of the parallel group designs did not randomize,and 6 of the 33 randomized trials did not use blinding.The trial stages were mainly phase I or phase II clinical trials,with 60 trials (92.21%).The main cell type studied was human umbilical cord mesenchymal stem cells (UC-MSCs),41 items(63.08%).The main indications were knee osteoarthritis (11 items,16.92%),graft-versus-host disease (7 items,10.77%),and ischemic stroke (7 items,10.77%).At present,only one MSCs therapy (Amimestrocel Injection) has been approved in China. Conclusions The clinical trials of MSCs in China are mainly concentrated in areas with well-developed economic and medical resources,and the study designs are not standardized.The experimental cell type was mainly UC-MSCs,with a focus on the treatment of knee osteoarthritis.At present,most studies are still in phase I-II clinical trials,and there is a lack of definitive clinical safety and efficacy data;it will take time for them to be approved for marketing.The future development of MSCs clinical trials in China should focus on precision and enhanced therapies,and strive to advance the maturity of the entire industry chain and the synergy of interna-tional cooperation and regulation.
Dichloroacetate (DCA) is a pan-inhibitor of pyruvate dehydrogenase kinase (PDK).PDK inhibits the pyruvate dehydrogenase complex (PDC),thereby promoting a shift in cellular metabolism from oxidative phosphorylation towards aerobic glycolysis (the Warburg effect).By inhibiting PDK,DCA activates PDC,reverses aerobic glycolysis,enhances mitochondrial oxidative phosphorylation,and reduces lactate production.In recent years,with the in-depth study of the glycolytic pathway in tumors and inflammatory diseases,an increasing number of studies have revealed the potential clinical value of DCA in inflammatory diseases.This article reviews the research progress regarding the anti-inflammatory activity and mechanisms of DCA in various inflammatory diseases,aiming to provide references for both basic research and clinical applications of DCA in these conditions,as well as to offer new perspectives for the treatment of inflammatory diseases.
The antipsychotic drugs developed and clinical trials were summarized in this review.Compared with the first- and second-generation antipsychotic drugs,the third-generation antipsychotic drugs show better therapeutic efficacy.Currently,antipsychotic drugs still face challenges,including inadequate efficacy for treatment-resistant symptoms,lack of indications for pediatric and geriatric patients,as well as safety,tolerability,and side effect concerns in clinical trials.In the future,drug development should focus on novel targets or multi-target synergistic drugs to develop more potent antipsychotics with fewer side effects.Meanwhile,clinical trials should prioritize long-term effectiveness,precision,and personalized medicine,as well as multi-dimensional assessments.This research provided insights into the future direction of antipsychotic drug development and clinical trials.
Invasive fungal disease (IFD) has emerged as a critical global public health challenge due to its high morta-lity rate.Posaconazole,a broad-spectrum triazole antifungal agent,plays a pivotal role in both prophylaxis and treatment of IFD.However,its pharmacokinetic profile exhibits significant interindividual variability in plasma concentrations,influenced by multiple factors including formulation characteristics,gastrointestinal conditions,and drug-drug interactions.To ensure the safety and efficacy of antifungal therapy,therapeutic drug monitoring (TDM) of posaconazole plasma concentrations becomes particularly essential.Population pharmacokinetic (PPK) models facilitate individualized dosing optimization by integrating covariates,thereby providing scientific evidence for precise dose adjustment.This review systematically analyzes the exposure-response relationships between posaconazole concentrations and therapeutic outcomes/adverse effects,based on a comprehensive evaluation of domestic and international literature.It further elucidates the impacts of formulation variations,pathophysiological status,and drug interactions on drug exposure,while summarizing recent advances in PPK model development.The synthesis aims to establish a reference framework for precision medication of posaconazole in clinical practice.
Postoperative pain refers to the pain sensations following surgical or medical procedures.It may result from tissue damage,incisions,or surgical stimulation,as well as postoperative inflammatory responses,nerve damage,or other physiological changes.The intensity and duration of postoperative pain vary depending on the type of surgery,individual differences,and treatment approaches.Enhanced Recovery After Surgery (ERAS) is a multidisciplinary collaborative model based on evidence-based medicine that aims to optimize perioperative management and reduce patients' physical and psychological traumatic stress,thereby accelerating recovery.In recent years,advances in pharmacological and clinical research have led to widespread use of magnesium sulfate in the treatment of various acute and chronic pain conditions.Accordingly,this review summarizes the application of magnesium sulfate in postoperative analgesia and ERAS,providing references for its clinical utilization.
Objective To optimize the preparation process and establish a thin-layer identification method of Jiawarixi Kundu'er honey paste. Methods The crushing process of eight drugs were determined from different crushing methods;The honey refining process was optimized to prepare suitable honey with the degree of foam expulsion,water content and yeast number as indicators;Based on indicators such as water content,appearance,mixing difficulty and foaming,the molding process of honey paste was determined.Thin layer chromatography (TLC) was used to establish the qualitative identification of Olibanum and Zingiberis Rhizoma in the preparation. Results The process parameters were determined as follows: Olibanum,which was separately frozen and crushed,and artificial musk,which was grinded and crushed,were added into the mixed powder of the remaining six herbs in an equal incremental method.The honey refining temperature was 105-115 ℃,the water content of honey was 15%-17%,and the intermittent boiling times were 4-6.The TLC results showed clear spots on the characteristic medicinal herbs,and the negative control had no interference. Conclusion The optimized preparation process,which is stable,and the established TLC method,which has strong specificity,can be used for the preparation and quality control of Jiawarixi Kundu'er honey paste.
Objective To establish an optimized extraction process for Coptis chinensis inflorescence using orthogonal design combined with a multi-indicator combination empowerment method. Methods Using an L9(34) orthogonal array for single-factor experiments,we systematically tested extraction parameters,including water-to-material ratio,extraction time,and extraction cycles.HPLC quantified the content of berberine hydrochloride,while the total alkaloid content was determined by UV spectrophotometry.In addition to the dry extract yield,these parameters served as evaluation indicators.A comprehensive evaluation was performed by integrating subjective weights from the Analytic Hierarchy Process and objective weights from the Entropy Weight Method and Independence Weight Method. Results The weighted multi-indicator combination empowerment method determined the optimal extraction conditions for Coptis chinensis inflorescence as follows: water-to-material ratio of 14:1,three extraction cycles,and 60 minutes per cycle. Conclusion The optimization of the extraction process for Coptis chinensis inflorescence using the combined analytic hierarchy process,entropy weight method,and independence weight method is rational and re-liable,establishing a foundation for its further development and application.
Objective To optimize the extraction process of rutin,quercetin,and kaempferol,three major flavonoid components,from Gynostemma pentaphyllum. Methods A HPLC method was used to analyze the content.The total extraction yield of three flavonoid components-rutin,quercetin,and kaempferol-was selected as the evaluation index.The optimal deep eutectic solvent system was determined by examining the type,molar ratio,and water content of the deep eutectic solvent.Box-Behnken response surface methodology was used to investigate the effects of liquid-solid ratio,ultrasonic temperature,and ultrasonic time on the extraction of Gynostemma pentaphyllum flavonoid components to determine the optimal extraction conditions. Results The optimum extraction process of three flavonoid components from Gynostemma pentaphyllum was as follows: the solvent composition consists of choline chloride and oxalic acid at a molar ratio of 3:1,with a water content of 30%.Additionally,the liquid-to-solid ratio is maintained at 35 mL·g-1,the ultrasonic temperature is set at 69 ℃,and the ultrasonic duration is 40 minutes. Conclusion The optimized deep eutectic solvent-based extraction method demonstrates stability and feasibility,providing a reliable approach for the efficient and safe extraction of flavonoids from Gynostemma pentaphyllum.
Objective To develop the Summary Table for the Rational Drug Use of Chinese Patent Medicines Containing Toxic Decoction Pieces (hereinafter referred to as the Summary Table),aiming to provide a rapid reference for clinical medication safety and to evaluate its application value preliminarily. Methods A study was conducted on Chinese patent medicines available in Xiyuan Hospital,China Academy of Chinese Medical Sciences,from April to June 2025.Data were systematically integrated from drug package inserts,the China National Knowledge Infrastructure (CNKI) database,specialized reference texts (e.g.,Toxicity and Detoxification of Chinese Medicines and Hundred Toxins Detoxification Formulas),and online user feedback.Information concerning adverse drug reactions (ADRs) / medication-related injuries associated with these medicines,potential ADRs/medication-related injuries of the contained toxic decoction pieces,contraindications for special populations,and detoxification protocols was extracted and synthesized.The names of the medicines in the Summary Table were systematically sorted using the first-letter alphabetical order method to construct the framework,enabling the structured presentation of information. Results A total of 119 Chinese patent medicines containing toxic decoction pieces were included.Common ADRs/medication-related injuries primarily manifested as gastrointestinal reactions and allergic reactions.Possible severe ADRs/medication-related injuries involved damage to the nervous,circulatory,and respiratory systems,as well as hepatorenal dysfunction.The Summary Table achieved systematic integration of ADR/medication-related injury identification,medication contraindication alerts,and emergency management of poisoning through a categorized organization.Feedback from clinical application indicated that the Summary Table possesses high practical value in enhancing healthcare professionals' confidence in medication use,avoiding irrational drug combinations,and promoting rational drug use. Conclusions The Summary Table for the Rational Drug Use of Chinese Patent Medicines Containing Toxic Decoction Pieces,as a clinical auxiliary tool,can effectively improve the safety and rationality of using these medications.It demonstrates good applicability and potential for widespread adoption,although further strengthening the evidence grade and establishing a dynamic updating mechanism are still required.
Objective By comparing the classification of traditional Chinese medicine (TCM) syndrome types for cough with the recommended TCM compound prescriptions/proprietary medicines in current guidelines and textbooks,this study aims to provide a scientific basis and new ideas for the rational clinical use of cough-related TCM compound prescriptions and proprietary medicines. Methods Relevant guidelines,expert consensuses,textbooks,and industry standards on cough were systematically collated and analyzed.Syndrome types with synonymous or similar concepts were integrated,and high-frequency syndrome type names were screened out.Statistical analysis was then performed on the recommended therapeutic prescriptions corresponding to these syndrome types. Results A total of 10 guidelines,expert consensuses,textbooks,and industry standards related to TCM syndrome types of "cough" were included,covering 47 syndrome type names.Seven high-frequency syndrome types were identified,namely: Wind-Cold Invading the Lung Syndrome,Wind-Heat Attacking the Lung Syndrome,Wind-Dryness Injuring the Lung Syndrome,Phlegm-Dampness Amassing in the Lung Syndrome,Phlegm-Heat Stagnating in the Lung Syndrome,Liver-Fire Invading the Lung Syndrome,and Lung-Yin Deficiency Syndrome.A total of 44 TCM compound prescriptions/proprietary medicines were recommended in the research data,including San'ao Decoction combined with Zhisou Powder,Tongxuan Lifei Oral Liquid (pill,capsule),Xiaoqinglong Granules (tablet,granule),Chuanbei Pipa Syrup (dripping pill),Qingjin Huatan Decoction,and Baihe Gujin Oral Liquid (tablet,pill),etc. Each recommended TCM compound prescription/proprietary medicine has its own characteristics in clinical application;however,problems such as inconsistent syndrome type classification,differences in recommendation frequency,and non-unified classification standards for proprietary medicines still exist.For example,Maxing Zhike Syrup was classified as a "Phlegm-Heat Stagnating in the Lung preparation" in the Chinese Expert Consensus on Public Education for Cough (First Edition),but it is more consistent with Wind-Heat Attacking the Lung Syndrome when combined with clinical symptoms and diagnostic criteria.On this basis,integrating the formulation efficacy characteristics and clinical application practice of proprietary medicines,the above cough-related TCM proprietary medicines were reclassified from four dimensions: (1) Status of toxic medicinal slices (prescriptions containing toxic slices vs.those without);(2) Cold-heat nature of the entire prescription (cold-natured prescriptions,hot-natured prescriptions,prescriptions combining cold and hot properties);(3) Derivative prescription perspective (Maxing Ganshi Decoction series prescriptions);(4) Efficacy characteristics (phlegm-focused treatment,cough-focused treatment,combined treatment of phlegm and cough,asthma relief;simultaneous treatment of lung and spleen,simultaneous treatment of lung and kidney).Corresponding recommendations for rational drug use were proposed. Conclusions Existing guidelines,expert consensus,textbooks,and industry standards related to cough treatment exhibit inconsistencies in the classification of TCM syndrome types and in the recommendations for therapeutic TCM proprietary medicines/compound prescriptions.These differences have affected the accuracy of clinical syndrome differentiation and treatment,as well as the rational use of cough-related TCM proprietary medicines/compound prescriptions.To further improve clinical efficacy and safety,it is urgent to establish a unified classification standard for syndrome types and standardize the clinical application of such TCM proprietary medicines/compound prescriptions.
Objective To explore the effect of the pharmacist-nurse joint service model on the pain management of children. Methods A historical control study was conducted.The control group (100 cases) consisted of children who received routine diagnosis,treatment,and care after orthopedic surgery from January to March 2023.The treatment group (92 cases) consisted of children who received the pharmacist-nurse joint pain management model service after orthopedic surgery from June to August 2023.The age,gender,diagnosis,preoperative pain score,postoperative pain score,hospitalization period,postoperative ambulation time,medication compliance score,children's self-assessment of pain ability,frequency of non-steroidal anti-inflammatory drug use,analgesic course,and combined analgesia were compared between the two groups. Results Compared with the control group,the postoperative pain scores of the treatment group at 4 hours,24 hours,48 hours,and 72 hours were all relieved,the pharmacist-nurse joint intervention did not affect on the hospitalization period,but had a significant effect on the postoperative ambulation time,medication compliance score,and children's self-assessment of pain ability;the frequency of non-steroidal anti-inflammatory drug use,analgesic course,and combined analgesia in the treatment group were significantly increased(all P<0.01). Conclusion The pharmacist-nurse joint pain management model improves the work efficiency of pain pharmacists,increases children's and parents' understanding of pain,pain assessment skills,and medication compliance,improves children's quality of life,and promote the recovery of joint function.
Objective To explore individualized treatment strategies for a pediatric patient with methicillin-resistant Staphylococcus aureus (MRSA) bone and joint infection (BJI) complicated by bloodstream infection (BSI). Methods A clinical pharmacist participated in the management of this pediatric case.By analyzing factors related to the infection site (penetration),the pathogen,and the drug itself,the reasons for the suboptimal response were identified.Based on the pathogen profile,international guidelines,and pharmacokinetic principles,an evidence-based recommendation was provided to switch to a daptomycin regimen.Key issues for its individualized use in children,including dosage,therapeutic drug monitoring,and treatment duration,were discussed. Results In this pediatric case of MRSA BJI with BSI,the initial vancomycin therapy was assessed as ineffective after 14 days.The clinical pharmacist identified potential contributing factors,including possible MRSA biofilm formation,vancomycin minimal inhibitory concentration (MIC) creep,insufficient drug penetration at the infection site,inadequate drug exposure,and a relatively delayed surgical drainage.Consequently,a switch to daptomycin (6 mg·kg-1 once daily) was recommended.This modified regimen led to a rapid clinical response,with fever resolution within 24 hours,followed by a steady decline in inflammatory markers and negative blood cultures.After 2 weeks of daptomycin treatment,the patient's condition improved significantly,leading to discharge and full recovery.No drug-related adverse reactions were observed during the treatment course. Conclusions ①Assessment approach: Response evaluation should extend beyond trough vancomycin levels to integrate pathogen MIC and infection site characteristics;②Treatment option: Daptomycin serves as an effective salvage therapy for pediatric MRSA BJI/BSI following vancomycin failure;③Implementation phase: A daptomycin dosage of 6 mg·kg-1 once daily,complemented by therapeutic drug monitoring and creatine kinase surveillance,can optimize efficacy and ensure safety.
Objective To examine clinical pharmacists'pharmaceutical care for patients with primary aldosteronism (PA) who are on long-term aromatase inhibitor therapy after breast cancer surgery,with a focus on managing the potential hormone-related adverse effects of spironolactoneand promoting safer clinical practice. Methods Clinical pharmacists analyzed the case of a breast cancer survivor with inadequately controlled hypertension and concurrent primary aldosteronism while undergoing aromatase inhibitor therapy.The clinical challenge of balancing breast cancer recurrence risk and antihypertensive drug selection was addressed.As a member of the treatment team,the clinical pharmacist assessed potential drug interactions and clinical risks between spironolactone and the aromatase inhibitor.Using an evidence-based approach,the pharmacist provided recommendations that helped formulate an individualized treatment plan. Results Ultimately consisting of low-dose spironolactone combined with amlodipine and sacubitril/valsartan. The patient achieved well-controlled blood pressure during hospitalization and follow-up,with no drug-related adverse events observed,leading to clinical improvement and discharge. Conclusions This case illustrates that in breast cancer survivors with PA,drug therapy must effectively control blood pressure and potassium levels while giving due attention to hormone-related safety.By carefully evaluating drug interactions and designing tailored regimens,clinical pharmacists can help harmonize treatment objectives across comorbidities,optimize therapeutic outcomes,and reduce overall treatment risks.
Objective To explore anticoagulant drug selection,pharmaceutical care,and precautions for patients at high thrombotic risk who develop heparin resistance following traumatic cerebral hemorrhage,using a rare clinical case as an example. Methods Clinical pharmacists intervened in the anticoagulation therapy of a patient with traumatic cerebral hemorrhage combined with antithrombin Ⅲ(AT-Ⅲ) deficiency.The cause of resistance was analyzed,the regimen was adjusted promptly,and comprehensive pharmaceutical monitoring was implemented throughout treatment. Results The patient's thrombotic risk was effectively controlled,with no thrombotic or hemorrhagic events occurring during hospitalization or follow-up. Conclusions Timely intervention by clinical pharmacists enabled effective identification of heparin resistance and determination of its etiology.Through evidence-based evaluation and multidisciplinary consultations,the anticoagulation regimen was optimized,achieving favorable therapeutic outcomes.
Objective To establish an intelligent regulatory system for the coordinated supervision of centrally procured drugs and non-selected originator drugs,thereby enhancing the level of refined clinical medication management. Methods This study adopted a pre-post design.Data were extracted from the clinical medication decision support system and visualized using the Yaoshitong program.Based on the data before and after system implementation,a paired t-test was performed in SPSS to evaluate the utilization rate of selected drugs,the balance of task completion,and the progress of task completion. Results Data extraction via the clinical medication decision support system,combined with analysis and visualized results presentation through the Yaoshitong program,enables rapid access to the fulfillment progress of centralized procurement drug procurement volume commitments,the distribution of usage ratios between selected drugs and non-selected originator drugs,and the monitoring and analysis of drug utilization patterns in specific clinical departments.After the monitoring system was implemented,the overall utilization rate of selected drugs increased significantly compared to the pre-monitoring period (average increase of 15.65%,P=0.044),the task completion balance for selected drugs also improved significantly (an 18.56% decrease from baseline,P=0.016),and the task progress for all selected drug varieties rose above the timeline threshold. ConclusionThe multidimensional monitoring and visualization analysis platform,built upon the clinical medication decision support system and Yaoshitong, effectively ensures the implementation efficiency of centralized procurement policies while balancing clinically appropriate medication needs with the personalized selection of originator drugs.
Objective To summarize and analyze the transportation situation of pharmaceutical products,and to discuss methods available for performance testing of the transport packages of pharmaceutical products. Methods Research on the current status of pharmaceutical product transport packages systematically summarizes relevant testing standards at home and abroad,compares and analyzes differences in testing procedures and conditions across different standard systems,and summarizes and analyzes the transportation characteristics of pharmaceutical products. Results A testing plan and recommended procedure for transporting packages of pharmaceutical products were provided,and the test process was illustrated with a specific case. Conclusion The performance testing of the transport packages for pharmaceutical products is of great significance in ensuring drug quality.